Clinical trial for Graft Failure
Official title Allo HSCT for High Risk Hemoglobinopathies
ClinicalTrials.gov ID: NCT06872333
What this study is testing
What is Alemtuzumab?
An investigational intravenous monoclonal antibody being studied as a potential treatment for graft failure in stem cell transplant patients. It is designed to bind to the CD52 protein on immune cells and deplete them, which may help reduce rejection of the transplanted cells.
Also referred to as Campath.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study is looking to find out whether an allogeneic hematopoietic stem cell transplant is safe and effective for high‑risk hemoglobinopathies and other red‑cell transfusion‑dependent conditions.
- Who it's for
- People with high‑risk hemoglobinopathies or other disorders that require regular red blood cell transfusions.
- What's involved
- Participants will receive a stem cell transplant from a donor (allogeneic HSCT) and will have regular clinic visits and medical tests to monitor their health.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 55. Healthy volunteers may be eligible.
You may be able to join if
- Sickle Cell Disease (SCD)
- SCD Patients with a fully matched sibling donor (MSD) irrespective of the frequency or severity of symptoms MSD transplant can be considered.
- Transfusion Dependent Alpha- or Beta- Thalassemia
- Diamond Blackfan Anemia
- Other Non-Malignant Hematologic Disorders
You likely can't join if
- Pregnant, breastfeeding or intending to become pregnant during the study.
- HIV infection with a detectable viral load. All HIV+ patients must be evaluated by infectious disease (ID) and an HIV management plan established...
- Active, uncontrolled infection - infection that is stable or improving after 1 week of appropriate therapy (4 weeks for presumed or documented fungal...
- Known allergy to any of the study components
- Psychiatric illness/social situations that, in the judgement of the enrolling Investigator, would limit compliance with study requirements
- Other illness or a medical issue that, in the judgement of the enrolling Investigator, would exclude the patient from participating in this study
See the full eligibility criteria
- Sickle Cell Disease (SCD)
- SCD Patients with a fully matched sibling donor (MSD) irrespective of the frequency or severity of symptoms MSD transplant can be considered.
- Transfusion Dependent Alpha- or Beta- Thalassemia
- Diamond Blackfan Anemia
- Other Non-Malignant Hematologic Disorders
- Karnofsky ≥ 60%, Lansky play score ≥ 60. Patients with lower performance score can be considered based on study team's evaluation.
- Sexually active persons of childbearing potential or persons with partners of childbearing potential must agree to use a highly effective form of contraception during study treatment and for at least 4 months after the...
- Pregnant, breastfeeding or intending to become pregnant during the study. Persons of childbearing potential must have a negative pregnancy test (serum or urine) within 30 days of the start of treatment
- HIV infection with a detectable viral load. All HIV+ patients must be evaluated by infectious disease (ID) and an HIV management plan established prior to transplantation.
- Active, uncontrolled infection - infection that is stable or improving after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections) will be permitted
- Known allergy to any of the study components
- Psychiatric illness/social situations that, in the judgement of the enrolling Investigator, would limit compliance with study requirements
- Other illness or a medical issue that, in the judgement of the enrolling Investigator, would exclude the patient from participating in this study
The study team makes the final eligibility decision.
Where it is enrolling
- Minneapolis, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Minneapolis, Minnesota, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.